News | Artificial Intelligence | November 05, 2022

The FDA Office of Women’s Health has issued a Women’s Health Alert on MRI-guided breast biopsy grid plates

The FDA Office of Women’s Health has issued a Women’s Health Alert on MRI-guided breast biopsy grid plates

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Nov. 4, 2022 — The U.S. Food and Drug Administration (FDA) is recommending health care providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.

The FDA Recommends That Health Care Providers:

·      Discuss options with patients if MRI breast biopsy grid plates or other MRI coil disposables are not available at their facility.

·      Continue to schedule procedures if you have available supplies.

·      If supplies are unavailable, if possible, recommend an appointment at a facility where the procedure can be performed. The American College of Radiology maintains a list of Breast MRI facilities where biopsies may be performed.

·      Contact Philips for questions or assistance with shipment delays and shortages of breast biopsy grid plates using the Philips “Contact Us” form.

Background

On September 29, 2022, Philips issued a communication External Link Disclaimer on its website informing customers of shipment delays and shortages of certain productsExternal Link Disclaimer in its portfolio of MRI coil disposables and have instructed customers to contact Philips directlyExternal Link Disclaimer with questions or for assistance.

FDA Actions

The FDA is aware of the shortage and has worked with Philips to resume deliveries and to prioritize shipments to facilities in regions that have no alternative imaging centers where these procedures can be performed. Imaging facilities notified the FDA of this shortage in July 2022, and we have been working with Philips to identify potential contributing factors and mitigation strategies. The shortage is estimated to continue through the end of 2022.

On October 31, 2022, the FDA added certain product codes associated with MRI breast biopsy grid plates to the medical device shortage list. The device shortage list reflects the types of devices the FDA determined to be in shortage. The FDA will continue to update the list as needed.  The FDA also carefully reviews each notification under section 506J of the Federal Food, Drug, and Cosmetic Act received and uses this information, along with any additional details about the supply and demand of a device, to determine whether a device is in shortage.

The FDA continues to monitor the current situation and will continue to keep health care providers and the public informed if new or additional information becomes available.

Reporting Problems to the FDA

If you are experiencing supply issues, contact the FDA about a medical device supply chain issue. This information supports the FDA's shortage analysis that informs measures the FDA may be able to use to help address device supply availability.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with the Philips Invivo MRI breast biopsy grid plates or other MRI coil disposables. 

·      Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

·      Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

·      Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

 

For more information: www.fda.org


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